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AzTrials

VaricocelectomyNCT03750370

Color Doppler in Varicocelectomy in Infertile Patient

An observational study of Varicocelectomy and Doppler, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the long-term effects of varicocelectomy on testicular arterial flow via Color Doppler Sonography Parameters; The arterial flow velocities (peak systolic velocity [PSV] and end diastolic velocity [EDV]) and the resistance indices against this flow (resistive index [RI] and pulsatility index [PI]) of the… Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Varicocelectomy, Doppler
What is being tested?
Doppler ultrasound
Type of treatment
Medical device
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Jan 2019to Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Egyptian Population , Random Selection of 50 patients with varicocele in the waiting list of varicocelectomy either open or laparoscopic approaches

Who may be able to join

  • Patients with subfertility in different age groups with either unilateral or bilateral clinical varicoceles and at least one abnormal semen parameter.

Who cannot join

  • Patients with varicocele with normal semen parameters.
  • Fertile Patients with varicoceles seeking operation only to relieve pain and heaviness.
  • Patients with recurrent varicoceles after operation.

Trial locations and contacts

1 site in 1 country.

Mahmoud Mohammad Aly, M.B.B.CH contact

00201011367958

am.8892@gmail.com

Eman Abu- EL-Hamd, Professor contact

01001980793

dr.eman_08@yahoo.com

Egypt1 site, 1 recruiting
  • Faculty of Medicine of Assuit

    Asyut, 71515

    Recruiting

Other trials in Egypt

About this study

Official title: Role of Colored Doppler Sonography in Evaluation of Testicular Perfusion Before and After Varicocelectomy in Patients With Infertility

To evaluate the long-term effects of varicocelectomy on testicular arterial flow via Color Doppler Sonography Parameters; The arterial flow velocities (peak systolic velocity [PSV] and end diastolic velocity [EDV]) and the resistance indices against this flow (resistive index [RI] and pulsatility index [PI]) of the testicular artery.

Read the detailed description

Introduction Varicocele, an abnormal dilatation of the internal spermatic veins, is considered the major reversible cause of male infertility. It is observed in 35%-40% of all men with primary infertility and in up to 80% of those with secondary infertility.

The higher incidence of varicocele in men with secondary infertility suggests its progressive nature, which might be explained by a progressive testicular dysfunction involving both spermatogenesis and steroidogenesis. The negative impact of varicocele on spermatogenesis has been documented by a progressive reduction in the size of testicle ipsilateral to the varicocele.

Semen parameters improvement after varicocele treatment were first reported by Tulloch in the mid-20th century, who performed high surgical ligation of varicose veins in 30 patients with infertility. The author showed a marked improvement in postoperative seminal parameters in 66% of the treated subjects.

Several theories have been formulated to explain the testicular impairment caused by varicocele, including hypoxia, autoimmunity, elevated testicular temperature, reflux of catecholamine, and increased oxidative stress. However, none of them can completely explain the variable modulating effect of varicocele on male fertility. Recently, the oxidative stress theory has emerged as an important contributory factor due to findings of an association between elevated reactive oxygen species and impaired sperm function in men with varicocele. Additionally, reduction of oxidative stress markers has been noted after varicocele repair.

It is hypothesized that impaired venous drainage causes an increase in venous stasis and a decrease in arterial blood flow, thus inducing hypoxia and deficiency in testicular microcirculation . Also, it is thought that this hypoxia could be responsible for defective energy metabolism at mitochondrial levels, causing dysfunction of both Leydig and germinal cells.

The arterial supply to the human testis has 3 major components: the testicular artery, the cremasteric artery, and the vasal artery. Two-thirds of total blood is supplied by the testicular artery. The testicular artery divides into 2 branches in the testis; the capsular branch continues in the surface of the testis, the intratesticular branch continues in the parenchyma and deep into the testis.

Colored Doppler Sonography is well established to illustrate microvascularity and therefore perfusion of the testis. The arterial flow velocities (peak systolic velocity [PSV] and end diastolic velocity [EDV]) and the resistance indices against this flow (resistive index [RI] and pulsatility index [PI]) in the testis can be measured with this technique.

The encouraging benefits of varicocele repair to the semen parameters of subfertile men were ratified by three recent meta-analyses:

Agarwal et al. pooled 17 studies that included only infertile men with clinical varicocele and with at least one abnormal semen parameter. The intervention was either high ligation of the veins or subinguinal microsurgical varicocelectomy. There was a consistent improvement in sperm concentration and motility after both high ligation and microsurgical subinguinal techniques, with better results after microsurgical approach. Sperm morphology change was not stratified according to the type of intervention; nevertheless, there was an increment of 3.16% on the average of normal forms.

Baazeem et al. have also evaluated the role of varicocele repair on semen analysis. They pooled 22 studies of various designs, including meta-analyses as well as randomized and nonrandomized prospective controlled studies, and analyzed sperm concentration before and after repair of clinical varicoceles in men with infertility and abnormal semen parameters. The authors found an overall increase in sperm concentration of 12.32 × 106 ml-1 from before to after interventions. In their study, sperm motility data were available from 17 prospective studies. Using the random-effects model a combined increment of 10.86% in motility was demonstrated. They also evaluated five prospective studies reporting the percentage of progressive motile sperm and confirmed that a significant improvement has occurred as well. The pooled improvement in progressive sperm motility was 9.69% using the random-effects model.

Finally, Schauer et al. published a meta-analysis aiming to determine the impact of each type of intervention; namely, high ligation, inguinal varicocelectomy, and subinguinal varicocelectomy on the semen parameters of subfertile men. The aforementioned study pooled 14 articles including randomized controlled trials, interventional trials, and cohort studies, which accounted for 1476 subjects. Inclusion criteria comprised subfertility and/or at least one abnormal semen parameter, clinical varicocele, and 19 years of age or older. All the studied techniques led to a significant improvement in sperm count and motility. Only minimal differences were observed between intervention groups. The higher increment in sperm count and sperm motility was achieved by inguinal approaches, albeit of no clinical significance when compared to other techniques. The results of this meta-analysis indicated that varicocelectomy leads to significant improvements in sperm count and motility regardless of the chosen surgical technique.

Impaired venous drainage causes an increase in venous stasis and a decrease in arterial blood flow, thus inducing hypoxia, deficiency in testicular microcirculation and subsequent accumulation of oxygen free radicals.

Being tested
Doppler ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doppler ultrasoundDevice

    Colored Doppler Sonography is well established to illustrate microvascularity and therefore perfusion of the testis. The arterial flow velocities (peak systolic velocity [PSV] and end diastolic velocity [EDV]) and the resistance indices against this flow (resistive index [RI] and pulsatility index [PI]) in the testis can be measured with this technique.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate testicular perfusion before and after varicocelectomy

    Evaluation of testicular perfusion is done by Comparison between Doppler sonographic Parameters Peak systolic velocity ( Cm / sec) , End diastolic velocity ( Cm / sec) , Pulsatility index , And Resistive index Values Before and after varicocelectomy Operation.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study start1 Jan 2019
  3. Primary completionDec 2019 (estimated)
  4. Study completionApr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03750370
Sponsor's protocol ID
doppler in varicocelectomy
Status last verified
Jan 2019
First submitted
18 Nov 2018
Last updated
22 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tarhan S, Ucer O, Sahin MO, Gumus B. Long-term effect of microsurgical inguinal varicocelectomy on testicular blood flow. J Androl. 2011 Jan-Feb;32(1):33-9. doi: 10.2164/jandrol.109.009977. Epub 2010 Jul 29.

    PubMed 20671143
  • Zhang M, Du L, Liu Z, Qi H, Chu Q. The effects of varicocelectomy on testicular arterial blood flow: laparoscopic surgery versus microsurgery. Urol J. 2014 Nov 1;11(5):1900-6.

    PubMed 25361712
  • Akand M, Koplay M, Islamoglu N, Altintas E, Kilic O, Gul M, Kulaksizoglu H, Sivri M, Goktas S. Color Doppler ultrasound characteristics after subinguinal microscopic varicocelectomy. Med Ultrason. 2017 Jan 31;19(1):59-65. doi: 10.11152/mu-920.

    PubMed 28180198

Questions about this trial

What is this clinical trial studying?

An observational study of Varicocelectomy and Doppler, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mahmoud Mohammad Aly, M.B.B.CH (00201011367958, am.8892@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate testicular perfusion before and after varicocelectomy (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03750370, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.

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